MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT OFFSET 4MM PE HC LINER Ø32/C; HIP LINER

Model Number	01.32.3239HC4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03-apr-2023 lot 1810831: (b)(4) items manufactured and released on 01-mar-2019.Expiration date: 2024-02-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported cases during the period of review.Additional items involved in the event, batch review performed on 03-apr-2023 stem: m-vizion 01.22.411 proximal body ø20mm l 80mm lat with holes (k201471) lot.2115468 lot 2115468: (b)(4) items manufactured and released on 15-mar-2022.Expiration date: 2027-02-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported cases during the period of review.Ball heads: cocr 01.25.025 cocr ball head 12/14 ø 32 size xxl +10.5 (k072857) lot.152726a lot 152726a: (b)(4) items manufactured and released on 06-aug-2020.Expiration date: 2025-07-23.No anomalies found related to the problem.To date, only this item of the lot has been sold during the period of review.Father lot 152726: (b)(4) items manufactured and released on 15-sep-2015.Expiration date: 2020-08-31.No anomalies found related to the problem.Cup: mpact 01.38.052mh acetabular shell ø52 multi-hole (k171966) lot.2011324 lot 2011324: (b)(4) items manufactured and released on 27-apr-2021.Expiration date: 2026-04-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported cases during the period of review.
Event or Problem Description
The patient had competitor components and came in on (b)(6) 2023 for reasons unknown and the surgeon revised the competitor cup and liner with a medacta cup and liner, with the intention of revising the stem and head a week later.On (b)(6) 2023, the patient came back in and had the competitor stem and head revised with a medacta stem and head.On (b)(6) 2023, the patient was revised in order to put more anteversion in stem and an offset liner was implanted.Presently, on (b)(6) 2023, the patient came in reporting instability and the cause is unknown.The surgeon revised successfully stem, head, cup and liner.

• Brand Name: LINER: MPACT OFFSET 4MM PE HC LINER Ø32/C
• Common Device Name: HIP LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16806261
• Report Number: 3005180920-2023-00290
• Device Sequence Number: 7124941
• Product Code: LPH
• UDI-Device Identifier: 07630040730754
• UDI-Public: 07630040730754
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K183582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2024
• Device Model Number: 01.32.3239HC4
• Device Catalogue Number: 01.32.3239HC4
• Device Lot Number: 1810831
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female